Andrew Bathgate Email & Phone Number

Canberra, Australian Capital Territory, Australia

Canberra, Australian Capital Territory, Australia

Symonston, Australian Capital Territory, Australia

Perth Area, Australia

Responsibilities and Competencies• Maintain the currency and effectiveness of quality system documentation (ISO 13485 based) through a process of continual improvement.• Thorough knowledge of FDA, EU, TGA and Health Canada cGMP’s and corresponding Regulatory requirements.• Ensure ongoing internal audits of the quality management system are conducted.• Manage site calibration and validation programs.• Compiling and analysing department and company KPI’s and driving continuous improvement.• Manage the Supplier Evaluation System.• Review and sign-off on quality documentation including the release of product.• Manage the CAPA, Planned Deviation, Change Control, Continuous Improvement, Complaints, Pest Control and Non Conformance systems.• Project management of design control projects for new products and product updates, including write and review specifications, validation protocols and validation reports.• Act as Management Representative for the company.• Chair Management Review Meetings.• QA Representative in sponsored clinical trials to support regulatory submissions. Manage GCP compliance for contracted clinical services (Novartis drug trials). • Induction training of new staff in the quality management system and the ongoing training of existing staff.• Responsible for all day to day management and activities of the Quality and Regulatory Affairs department, including the development of the departmental budget.• Responsible for all Regulatory Affairs related activities associated with the commercial rollout of devices, including regulatory approvals, issues arising and maintenance of compliance and translation requirements in a variety of international jurisdictions.• Compiled two successful 510(k) submissions, one Aus/EU Regulatory submission and one FDA De Novo Companion Diagnostic submission.• Act as the company Privacy Officer.• Document and Record control.www.resonancehealth.com